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ASIA
RUSSIA
Market Information
Russia’s healthcare expenditure was estimated to amount to 138 billion U.S. dollars in 2022.
Market Trend: Medical care in Russia is provided at no cost to citizens and residents through the state insurance system known as Obligatory Medical Insurance (OMI).
Russia’s medical equipment market revenue is expected to show an annual growth rate (CAGR 2024-2028) of 2.99%, resulting in a market volume of US$3,732.00m by 2028.
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) is the federal body in Russia responsible for controlling and overseeing healthcare activities. Formerly known as the Federal Service for Surveillance of Health and Social Development until 2012, it was under the authority of the Ministry of Health and Social Development of the Russian Federation. Subsequently, between 2012 and 2020, it reported directly to the Government of the Russian Federation. Then, from 2020 onwards, it was once again placed under the authority of the Ministry of Health of the Russian Federation.
Medical Device Regulation
Federal Service for Surveillance in Healthcare (Roszdravnadzor), under the MOH.
http://government.ru/en/department/570/
Regulation of medical devices done under the Article 38 of the Health Law (Federal Law 323), Decree No. 1416 Medical Device Registration Rules & Decree No. 4n Medical Device Nomenclature Classification, Ministerial Ordinance No. 11 Technical and User Documentation Requirements.
Classification, Fees, Timeline
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Product Registration Routes
Class I
Class IIa
Class IIb
Class III
Useful Information
Validity of License: No expiry.
License transfer: Change of AR is needed.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
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